Channel Interaction in Cochlear Implant and Speech Understanding in Noise

NCT03877211 | Completed

• 1 other identifier: 69HCL17_0434
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to take into account channel interaction in the cochlear implant (CI) fitting process. Designing a fast and accurate method of measurement would help to customize the fitting procedures to patients' specificities in order to maximize speech understanding in every day conditions especially in noise.

Conditions

Cochlear Implants

Keywords

speech audiometry; psychophysical tuning curve; electrophysiology; auditory brainstem response

Outcome Measures

Primary Outcomes (1)

• Percentage of syllable correctly recognized during speech audiometry test

  Subjects will be asked to repeat lists of words played by speakers in a noisy environment generated by the same speakers. A percentage of correct recognition is calculated for each list.

  At inclusion

Secondary Outcomes (2)

• Sound masking threshold

  At inclusion

• Electrically-evoked Auditory Brainstem Response (eABR)

  Up to 12 months after inclusion

Study Arms (2)

Cochlear implant users

EXPERIMENTAL

Adult cochlear implanted patients wearing an Oticon Medical/Neurelec device will have speech audiometry test in noise, psychophysical tuning curves in forward masking and Electrically-evoked Auditory Brainstem Response (EABR) measurement

Other: speech audiometry in noise; Other: Psychophysical tuning curves in forward masking; Other: Electrically-evoked Auditory Brainstem Response (EABR)

Normal-hearing subjects

ACTIVE COMPARATOR

Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry

Other: speech audiometry in noise; Other: Psychophysical tuning curves in forward masking; Other: Tonal audiometry; Other: Auditory canal examination

Interventions

speech audiometry in noise OTHER

Subjects will be asked to repeat lists of words played by speakers in a noisy environment generated by the same speakers. A percentage of correct recognition is calculated for each list.

Cochlear implant users; Normal-hearing subjects

Psychophysical tuning curves in forward masking OTHER

Sounds of variable center frequency are used as maskers, and a tone with a fixed frequency at a fixed level is the target. What is tested here is the level of masker that just masks the target.

Cochlear implant users; Normal-hearing subjects

Electrically-evoked Auditory Brainstem Response (EABR) OTHER

Channel interaction assessment using eABRs (auditory nerve responses). The method consists of two measurements: 1) eABR measurements with stimulation by a single electrode of the cochlear implant at 70% of the dynamic range (four different electrodes are tested); 2) Measurement of a single eABR with stimulation from all four electrodes at 70% of the dynamic range. A comparison of the eABRs obtained by these two measurements, indicates the electrical and neural interactions between the electrodes.

Cochlear implant users

Tonal audiometry OTHER

Tonal audiometry will be performed with headphones

Normal-hearing subjects

Auditory canal examination OTHER

Otoscopic examination of external auditory canal and eardrum

Normal-hearing subjects

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Fluent in French
• Able to understand written instructions
• Under French public medical insurance
• Normal-hearing subjects only:
• Adult between 18 and 50 years old
• Without a remarkable otological medical history, for example: chronic otitis, trans-tympanic tubes and / or all ear surgeries;
• Clear auditory canal and normal eardrum;
• Average audiometric loss under 20 decibels Hearing Level (dB HL)
• Cochlear implant users only:
• Adult between 18 and 60 yo
• Normal middle ear
• Used the cochlear implant for more than a year
• Wearing a device from the company Neurelec/Oticon Medical

You may not qualify if:

• Behavioral and/or neurological disorders
• Proven psychological disorder
• Use of psychotropic medication
• People who experience migraine attacks on a regular basis
• Use of ototoxic medication
• Exposed to loud noises within the last 72 hours
• Included in another clinical trial that uses medication

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

ENT and Cervico-Facial Surgery Department, Hôpital Edouard Herriot

Lyon, 69003, France

Location

Related Publications (1)

• Cucis PA, Berger-Vachon C, Thai-Van H, Hermann R, Gallego S, Truy E. Word Recognition and Frequency Selectivity in Cochlear Implant Simulation: Effect of Channel Interaction. J Clin Med. 2021 Feb 10;10(4):679. doi: 10.3390/jcm10040679.

  PMID: 33578696 RESULT

MeSH Terms

Interventions

Noise

Intervention Hierarchy (Ancestors)

Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Environmental Pollution; Public Health

Study Officials

• Eric TRUY, MD, PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 15, 2019
• Study Start: February 24, 2019
• Primary Completion: February 18, 2021
• Study Completion: February 18, 2021
• Last Updated: September 4, 2025

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)